Surgical orientation device and method

ABSTRACT

A device for detecting and measuring a change in angular position with respect to a reference plane is useful in surgical procedures for orienting various instruments, prosthesis, and implants with respect to anatomical landmarks. One embodiment of the device uses three orthogonal rate sensors, along with integrators and averagers, to determine angular position changes using rate of change information. A display provides position changes from a reference position. Various alignment guides are useful with surgical instruments to obtain a reference plane.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/864,085, filed Jun. 9, 2004, which is hereby incorporated byreference in its entirety, which claims benefit under 35 U.S.C. §119(e)to U.S. provisional application 60/476,998 filed Jun. 9, 2003, which ishereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to medical orientation and positioningdevices and in particular to a device for orienting surgicalinstruments, implements, implants, prosthetics, and anatomicalstructures.

2. Description of the Related Art

Correct positioning of surgical instruments and implants, used in asurgical procedure, with respect to the patient's anatomy is often animportant factor in achieving a successful outcome. In certainorthopaedic implant procedures, such as totals hip replacement (THR) orarthroplasty, total knee arthroplasty (TKA), high tibial osteotomy(HTO), and total shoulder replacement (TSR), for example, the optimalorientation of the surgical implant enhances initial function and thelong term operability of the implant. A misaligned acetabular prostheticsocket, for example, can lead to complications such as dislocation ofthe hip joint, decreased joint motion, joint pain, and hastened failureof the implant.

Obtaining satisfactory orientation and positioning of a prostheticimplant is often a challenging task for orthopaedic surgeons. Currently,one technique for orientation and positioning is accomplished usingpurely mechanical instruments and procedures based on anatomicallandmarks. For example, the desired anteversion for an acetabular cupprosthesis within an acetabulum is accomplished by using externallandmarks associated with a patient's pelvis. These methods, however,are subject to misalignment caused by variations in these externallandmarks. These variations can be caused, for example, by failing toorient the patient's pelvis in the assumed neutral position on theoperating table. Other orientation and positioning techniques involvesophisticated computer imaging systems, which are typically expensiveand complicated to use.

There is a need in the art for an improved device and method forobtaining accurate orientation of surgical instruments and implantsduring various orthopaedic repair and replacement procedures. There is afurther need for a device that is simple and easy to operate.

SUMMARY OF THE INVENTION

The present invention, according to one embodiment is a surgicalinstrument for assisting a surgeon in obtaining correct orientation ofan acetabular prosthetic socket in a patient's acetabulum. Theinstrument includes a support shaft adapted for supporting theacetabular prosthetic socket, a three-dimensional electronic orientationdevice securely coupled to the support shaft, and an acetabularalignment guide having at least three arms, the arms having a lengthsufficient to each contact a rim of the acetabulum.

According to another embodiment, the present invention is an apparatusfor measuring and providing an indication of angular position withrespect to a reference. The apparatus includes a rate sensor initiallypositioned with respect to a reference and operative to measure a rateof change of angular position with respect to the reference and providea rate signal proportional to the rate of change of the angularposition. It also includes an integrator selectively connected to therate sensor and operative to integrate the rate signal and to provide anintegral signal indicative of the relative angular position of the ratesensor. It further includes an averager selectively connected to therate sensor and operative to average the rate signal and to provide anaverage signal indicative thereof. Finally, it includes a motiondetector connected to the rate sensor and operative to switch the ratesignal to (i) the averager when no motion is detected, and (ii) theintegrator when motion is detected.

The present invention, in yet another embodiment, is a method of usingan alignment instrument to align a prosthesis with an implant site. Themethod includes providing the instrument with a three dimensionalmeasuring system capable of measuring angular position changes from areference position, locating the instrument at a reference position withrespect to the implant site using an alignment guide to contact theimplant site, zeroing the measuring system while the alignment guide isin contact with the implant site and in the reference position,replacing the alignment guide with a prosthetic implant member, andpositioning the instrument to a desired angular orientation with respectto the reference position using the measuring system to align theprosthesis with the implant site.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the invention. As will be realized, theinvention is capable of modifications in various obvious aspects, allwithout departing from the spirit and scope of the present invention.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a surgical orientation device, accordingto one embodiment of the present invention.

FIG. 2 is a simplified block diagram of the rate sensor, systemelectronics, and display useful in the practice of the presentinvention.

FIG. 3 is a more detailed block diagram of one channel of threecorresponding to the block diagram of FIG. 2.

FIG. 4 is a still more detailed block diagram of one channel of thepresent invention, shown along with additional subsystems of the presentinvention.

FIG. 5 is a key for FIGS. 6 and 7.

FIG. 6 is a detailed electrical schematic of ROLL, PITCH and YAW sensorsand associated integrator and averager circuitry, useful in the practiceof the present invention.

FIG. 7 is a detailed electrical schematic of overrange, overrate, andmotion detectors and associated circuitry useful in the practice of thepresent invention.

FIG. 8 is a detailed electrical schematic of the additional subsystemsof FIG. 2.

FIG. 9 is a wiring diagram for certain parts of the present invention.

FIG. 10 is a detailed electrical schematic of an analog to digitalconverter and display for the ROLL channel of the present invention.

FIG. 11 is a detailed electrical schematic of an analog to digitalconverter and display for the PITCH channel of the present invention.

FIG. 12 is a detailed electrical schematic of an analog to digitalconverter and display for the YAW channel of the present invention.

FIG. 13 is a simplified block diagram of an alternative embodiment ofthe present invention.

FIG. 14 is a perspective view of an acetabular alignment instrument foruse in obtaining a desired orientation for a prosthetic acetabularsocket with respect to a patient's acetabulum, according to oneembodiment of the present invention.

FIG. 15 is a plan view of the top or distal face of the alignment guideshown in FIG. 14.

FIG. 16 shows a perspective view of an attachment base for attaching thedevice to the support shaft 304, according to one embodiment of thepresent invention.

FIG. 17 is a perspective view showing the instrument of FIG. 14 used toidentify the plane of the acetabular rim.

FIG. 18 is a perspective view showing the instrument of FIG. 14 used forpositioning an acetabular prosthetic socket.

FIGS. 19A and 19B are flow charts illustrating operation of an alignmentinstrument for orientation of an acetabular prosthetic socket.

FIG. 20 shows a femoral broaching instrument adapted for aligning thefemoral broach with the greater and lesser trochanter of the proximalfemur.

FIGS. 21A and 21B are top and side plan views of a femoral alignmentguide.

FIGS. 22A and 22B are a side plan view and a front plan view of animplant instrument and alignment guide for identifying the plane of theglenoid during a TSR procedure.

FIG. 23 is a flowchart describing the use of the alignment guide of FIG.22.

While the invention is amenable to various modifications and alternativeforms, specific embodiments have been shown by way of example in thedrawings and are described in detail below. The intention, however, isnot to limit the invention to the particular embodiments described. Onthe contrary, the invention is intended to cover all modifications,equivalents, and alternatives falling within the scope of the inventionas defined by the appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 is a perspective view of a surgical orientation device 10,according to one embodiment of the present invention. As shown in FIG.1, the device 10 includes a housing 12, a power switch 14, displays 18,a zero button 20, and indicator lights 22, 24, and 26. The housing 12contains the electronic circuitry and components necessary for deviceoperation. The housing 12 may be made from any material suitable for usewithin a surgical field or patient treatment setting. The device 12 maybe either disposable or reusable.

The displays 18, in the embodiment shown in FIG. 1, include a ROLLdisplay 18 a, a PITCH display 18 b, and a YAW display 18 c. Thesedisplays 18 provide an indication of the angular orientation of thedevice in three dimensions, which allow the device to function as athree-dimensional goniometer. The displays 18 may be a gauge of any type(e.g., analog meter, digital display, color bar, and thermocouplemeter), and may be integrated on the housing or part of a separate,stand-alone device. The indicator lights include a wait/ready or RUNindicator 22, a LOW BATTERY indicator 24, and an overrange or ERRORindicator 26. In one exemplary embodiment, the indicator lights (e.g.,LEDs) are integrated on the housing, to indicate when a positionalproperty of interest, such as a angle, has been reached and/or notreached and/or exceeded.

In one embodiment, the device 10 further includes attachment straps 28connected to the housing 12. The straps 28 are configured to allowattachment of the device 10 to a surgical instrument, implant, orprosthetic device. In one embodiment, the straps 28 are replaced withclips adapted for coupling with one or more surgical instruments. Thedevice 10 may be transferable from instrument to instrument within animplant system or systems, or may be dedicated for use with oneinstrument. In one embodiment, further discussed below, the device 10may in addition or in the alternative include sensors and displays forproviding linear positioning information. Also, the device 10 mayinclude only one or two of the ROLL, PITCH, and YAW displays 18 and therelated circuitry.

In one embodiment, the device includes the sensors, further describedbelow, for providing position and orientation signals. The sensor, forexample, may be directly integrated into the body of the housing 12 ormounted onto the body of the housing 12. The sensors may be adhered tothe housing 12, located inside the housing 12, or fabricated directly onthe surface of the housing 12, for example, by depositing a layer ofsilicon on the housing 12 by chemical vapor deposition (CVD) orsputtering, and then building the devices in this silicon layer usingtechniques common to or derived from the art of semiconductor or MEMSprocessing.

In another embodiment, the device 10 is adapted to receive orientationand positioning signals from sensors located in an external device. Thedevice 10 may have receptacles for attachment to such an external devicethrough direct cable or wireless communication capabilities such as RFand IR. In that embodiment, such an external device is attached to thesurgical instrument or prosthetic, and the device 10 is used by thesurgeon as an interface. In one such embodiment, the sensor isconnected, via wireless and/or wired connections, to a computer or otherelectronic instrument, which may record or display the sensormeasurements (e.g., temperature), and which may at least partiallycontrol or evaluate the sensor. For example, an auxiliary computer orother electronic instrument may at least partially control the sensorby, for example, performing sensor calibration, performing real-timestatistical analysis on the data from the sensor, or running errordetection and correction algorithms on the data from the sensor.

In one embodiment, the device 10 includes communication capabilities forinteracting with other equipment, for example, a computer generatedimage recreation system. It may, for example, be incorporated for usewith computer aided surgical navigation systems, such as VectorVisionavailable from BrainLab, Inc. of Germany, OrthoPilot, available fromAesculap, Inc. of Germany, HipNav, available from Casurgica, Inc., ofPittsburgh, Pa., and Navitrack, available from Orthosoft-CenterpulseOrthopedics, of Austin, Tex. In one such embodiment, data received froma sensor may be used by the computer system to control and/or modify aposition of an implant. The computer or other electronic instrument maybe configured to activate the appropriate controls or devices asnecessary based on the data received from the sensor. Manual adjustmentsmay also be made in response to the data received from the sensor. Inanother such embodiment, data from the sensor can be used in a feedbackloop with positioning elements (either directly, via a computer or otherelectronic instrument, or by manual control) to maintain a desiredproperty, such as an orientation or position.

Upon attachment of the device 10 to a surgical instrument, an operator,such as a surgeon for example, can use the device 10 to obtainthree-dimensional orientation information. This combination of thedevice 10 with a surgical instrument is useful for assisting surgicalprocedures wherein one anatomical part is desirably aligned with anotheranatomical part. For example, when a limb-to-torso joint replacement isto be performed (e.g., THR or TSR), it is desirable to orient an implant(such as an acetabular cup) with the anatomical part within which it isto be implanted (such as the acetabulum) so that the implant will beproperly positioned. For THR, the acetabular cup is desirably alignedwith respect to the plane of the acetabulum. The present inventionallows a surgeon to establish a reference plane corresponding to theplane of the acetabulum by positioning the device to physically alignthe device with the plane of the acetabulum and then zeroing the displaywhen the device is aligned with the plane of the acetabulum to establishthe reference plane. From then on, the device provides three dimensionalangular information (ROLL, PITCH, and YAW) to the surgeon as the deviceis moved angularly with respect to the reference plane. FIGS. 2-13 showblock diagrams and schematics illustrating the circuitry of the device10. FIGS. 14-20 illustrate alignment guides used for identifying thedesired reference plane, along with methods of using the presentinvention in joint replacement procedures.

Referring to FIG. 2, position information is obtained using an angularmeasurement and display system 30, preferably having three RATE SENSORblocks 32, 34, 36 which measure angular rate of change and deliverrespectively, ROLL, PITCH, and YAW information to a SYSTEM ELECTRONICSblock 38. The SYSTEM ELECTRONICS block converts the angular rate ofchange into angular position information and uses the DISPLAY block 40to provide ROLL, PITCH, and YAW information in a human readable form,and additionally or alternatively, in electronic form for use by othersystems, such as a data logger (not shown). An optional block 41 isshown in FIG. 2 to illustrate the communication capabilities mentionedabove. Block 41 represents a communication link which may be as simpleas a wire, or may include an interface which may be wired or wireless,and may encompass electrical, acoustical (preferably ultrasonic), radiofrequency, or optical communication technologies, all of which areconsidered to be within the term “electronic,” as that term is usedherein. It is to be understood that block 41 represents an output withthe angular orientation and (optionally) linear position informationmade available in a machine-readable (e.g., computer-compatible) format,while block 40 has a human readable display of the output information ina visually perceptable format.

Referring now to FIG. 3, a more detailed block diagram of one channel,e.g., the ROLL channel 42, may be seen. It is to be understood that theother two (PITCH and YAW) channels are preferably identical to the ROLLchannel 42. In FIG. 3, dashed line 38 encloses those blocks which formpart of the SYSTEM ELECTRONICS 38 for the ROLL channel 42. Furthermore,it is to be understood that DISPLAY 40 in FIG. 3 refers to the displayfunction for this channel, i.e., it includes a display of ROLL angularinformation.

For this channel, the RATE SENSOR 32 is preferably a MEMS(micro-electro-mechanical systems) device that provides angular rate ofchange information to a SWITCH block 44 and a MOTION DETECTOR AND DELAYblock 46. SWITCH block 44 receives command information from the MOTIONDETECTOR AND DELAY block 46 and directs the rate of change informationto either an INTEGRATOR block 48 or an AVERAGER block 50. A ZERO block52 permits resetting the INTEGRATOR 48 to a zero output in a manner tobe described.

Referring now also to FIG. 4, a more detailed block diagram 54 showsadditional details of one channel (with the ROLL channel 42 used as anexample) along with additional supporting functions of the SYSTEMELECTRONICS 38. Each channel includes a MOTION DETECTOR block 56 and aMOTION HOLD-ON DELAY block 58 within the MOTION DETECTOR AND DELAYfunctional block 46 which controls the operation of a relay type switch60 in SWITCH functional block 44 to switch between INTEGRATE and AVERAGEfunctions.

An OVERRANGE DETECTOR block 62 monitors whether the output of theINTEGRATOR block 48 reaches an OVERRANGE condition (corresponding to anangular position beyond which the system 30 is able to measure). AnOVERRATE DETECTOR block 64 monitors the output of RATE SENSOR block 32and provides an ERROR indication if the rate exceeds that which thesystem 30 is able to measure. Each of the blocks 62 and 64 are coupledto an ERROR LATCH block 66 which retains the ERROR condition (whetherrelated to range or rate or both) until reset by the ZERO block 52. ASTARTUP CONTROL block 70 monitors a POWER SUPPLY block 72 and the MOTIONHOLD-ON DELAY block 58 and provides a WAIT/READY signal at a RUNindicator 22. A LOW BATTERY DETECTOR block 74 is connected to the POWERSUPPLY 72 and controls a LOW BATTERY indicator 24.

Referring now to FIGS. 5, 6, and 7, FIG. 5 is a key to the electricalcircuit schematics shown in FIGS. 6 and 7, which are to be understood tobe joined at line 78. Dot dash line 80 separates the ROLL channel 42from a PITCH channel 84. Dot dash line 82 separates the PITCH channel 84from a YAW channel 86. Since the components and interconnections are thesame for each of channels 42, 84, and 86, only ROLL channel 42 will bedescribed, it being understood that the same description applies to eachof the other channels, as well.

ROLL sensor 32 (and the PITCH. and YAW sensors) are each preferably anADXRS150 150 degree/second angular rate sensor (gyroscope) on a singlechip, in a MEMS technology, available from Analog Devices, OneTechnology Way, P.O. Box 9106, Norwood, Mass. 02062-9106. It is to beunderstood that the ROLL, PITCH, and YAW sensors are mounted in aconventional orthogonal 3-dimensional (x-y-z) orientation. Each sensorproduces an output voltage RATEOUT that is proportional to the angularrate of rotation of that respective sensor. The output voltage isnominally 2.5 volts for zero rotation. The zero rotation output (orNULL) voltage varies from device to device, and with time and withtemperature. The RATEOUT voltage varies above and below NULL forpositive and negative rotational movement, respectively. The RATEOUTscale factor is typically 12.5 millivolts per degree per second with afull scale corresponding to 150 degrees per second. The ROLL sensorRATEOUT signal is also identified as a ROLL RATE signal. It is to beunderstood that each sensor responds in one plane only, and hence threeseparate sensors are mounted orthogonally to each other to achieveresponse in all three conventional mutually perpendicular (x, y, and z)axes.

The variation in sensor NULL voltage and the requirement to accuratelyprocess small rates of rotation make it desirable to establish anautomatically self adjusting NULL reference. When the system is notphysically rotating about any of the three x, y, z axes, the RATEOUTsignal is connected through SWITCH block 44 to a low pass filter toproduce an averaged representation of the RATEOUT voltage. This is theNULL voltage and it adjusts over time to sensor variations. When angularmotion is detected in one or more of the three x, y, z axes, the SWITCHblock (in response to an INTEGRATE signal [on line 140] from block 58,see FIG. 8) the RATEOUT signal is switched from the AVERAGER 50 to theINTEGRATOR 48.

At this time, since the input to the AVERAGER 50 is open circuited, theAVERAGER circuit 50 then enters a “hold” mode and retains the mostrecent previous NULL voltage, using that NULL voltage as a referencethroughout the duration of the motion. The ROLL channel 42 NULL voltageis buffered by an operational amplifier 88 and delivered as a ROLL S/Hsignal. The operational amplifier integrated circuits 88 in theINTEGRATOR and AVERAGER circuits 48 and 50 are preferably AD8606 type opamps, available from Analog Devices. AVERAGER circuit 50 uses a low passfilter made up of a 2 MEG ohm resistor 90 and a 0.47 microfaradcapacitor 92, resulting in a time constant of one second, which has beenfound to work well. However, it is to be understood that other partvalues and other time constants may be used, while still remainingwithin the scope of the present invention. The capacitor 92 preferablyhas a low leakage and low dissipation factor.

Angular position is the time integral of rotation rate. When motion isdetected, the SWITCH block transfers the RATEOUT signal to theINTEGRATOR circuit 48 to compute angular position. The output of theROLL INTEGRATOR 48 is available as a ROLL INT signal. INTEGRATOR circuit48 uses a 2.7 MEG ohm resistor 94 and a 0.47 microfarad capacitor 96 toperform the integration. The reference for the integration is theno-motion NULL voltage for that channel. The capacitor 96 preferably haslow leakage and a low dissipation factor. The integrating resistor 94 inconjunction with capacitor 96 provides a full scale range of over +120degrees.

The INTEGRATOR 48 is reset to zero by discharging the capacitor 96. Whenthe ZERO button 20 is depressed, relay 116 is energized by the ZEROsignal on terminal 118 (see FIG. 8). The relay 116 discharges capacitor96 through a 10 ohm resistor 120 to limit the discharge current.

Referring now most particularly to FIG. 7, in ROLL channel 42,integrated circuit comparators 98 are preferably LM393 type low power,low offset voltage comparators, available from National SemiconductorCorporation, 2900 Semiconductor Drive, P.O. Box 58090, Santa Clara,Calif., 95052-8090. If the sensor 32 is rotated too fast, the sensoroutput will saturate and the display would be incorrect. Similarly ifthe sensor is rotated through too great an angle, the integrator willsaturate and the display would be incorrect. OVERRATE and OVERRANGEdetectors 64 and 62 are provided to warn the operator in the event ofthe occurrence of either or both of these errors. There are threeOVERRATE detectors and three OVERRANGE detectors, one pair for each ofaxes x, y, z, corresponding to ROLL, PITCH, and YAW channels 42, 84, and86. Each channel has a window comparator circuit for each of theOVERRANGE and OVERRATE detectors. The comparators 98 in the OVERRATEcircuit 64 provide the OVERRATE signal on a terminal 100, and thecomparators 98 in the OVERRANGE circuit 62 provide the OVERRANGE signalon a terminal 102. Comparators 98 in circuit 64 monitor and compare theROLL RATEOUT signal to a fixed level, and comparators 98 in circuit 62compare the output of the ROLL INTEGRATOR circuit 48 to a fixed level.When the RATEOUT signal exceeds a predetermined level, either positiveor negative, the window comparator made up of comparators 98 in theOVERRATE circuit 64 determines that the system is in an OVERRATE errorcondition. The threshold is set to approximately 150 degrees per secondby a tap on the voltage divider string 122.

The output of the ROLL INTEGRATOR circuit 48 is sent to another windowcomparator made up of integrated circuit comparators 98 in the ROLLportion or channel of OVERRANGE circuit 62. When the INTEGRATOR circuitoutput (ROLL INT) exceeds a predetermined threshold, the ROLL channelportion of circuit 62 determines that the system is in an OVERRANGEerror condition. The threshold is set at approximately 120 degrees by atap on the voltage divider string 122. The twelve comparators incircuits 62 and 64 have open collector outputs. The six OVERRATE outputs(including the ROLL OVERATE output at terminal 100) together with thesix OVERRANGE outputs (including the ROLL OVERRANGE output at terminal102) are connected together. Both terminals 100 and 102 (i.e., alltwelve comparator outputs) are connected to terminal 104 in the ERRORLATCH circuit 66 (see FIG. 8) and form the OVER signal. The OVER signalgoes LOW whenever any one of the twelve comparators senses an errorcondition. Terminal 104 receives the OVER signal as an active LOW signalsetting a type 74HC74 D type flip flop 150, available from FairchildSemiconductor Corporation, 82 Running Hill Road, South Portland, Me.04106. The flip-flop 150 is configured as a SET-RESET memory element.The “Q” output drives the ERROR indicator 26, which is preferably a redLED. The flip-flop 150 is reset by the ZERO signal on terminal 118.

Comparators 98 in the MOTION DETECTOR circuit 56 compare the output ofthe ROLL rate sensor 32 to a fixed level and provide a MOTION signalrepresentative of whether the ROLL rate sensor 32 has experienced motionor not. When rotational motion is detected, the RATEOUT signal deviatesfrom the NULL or no-motion voltage. The RATEOUT signal is sent to a“window” comparator made up of comparators 98 in the MOTION DETECTORcircuit 56. When the RATEOUT signal deviates from the NULL voltage by apredetermined amount or threshold (either positive or negative) thewindow comparator detects rotational motion. A threshold of one degreeper second has been found to be preferable, but it is to be understoodto be within the scope of the present invention to use other values, inthe alternative.

A tap on a voltage divider string 122 sets the ROLL comparator MOTIONthresholds. The divider 122 is connected between +5 A 124 and circuitcommon 126, with the center point connected to the NULL voltage (ROLLS/H) line 128. This provides that the thresholds are referenced to theNULL voltage and compensates for drift and device-to-device variationsin the NULL voltage. The MOTION signal appears on terminal 106 in MOTIONDETECTOR circuit 56 and is connected to corresponding MOTION terminal106 in the MOTION HOLD-ON DELAY circuit 58 (see FIG. 8). Each ofcircuits 56, 62, and 64 are provided with a pair of comparators 98 inthe ROLL channel 42 so as to provide a bipolar (±) comparator function.All six MOTION comparators (including ROLL channel comparators 98) inchannels 42, 84 and 86 have open collector outputs which are connectedtogether via MOTION terminal or line 106. It is to be understood thatthe signal on MOTION line 106 will go to a LOW state whenever any one ofthe six comparators senses motion. Referring now also to FIG. 8, andmore particularly, to circuit 58, when the MOTION signal on terminal 106goes LOW, a 1 microfarad capacitor 130 will discharge through a 14.8Kohm resistor 132 causing a comparator 134 to deliver a HIGH output online 136. This turns on an IRFD 110 type FET transistor 138 which pullsthe INTEGRATE line 140 LOW. The IRFD 110 type FET transistor isavailable from International Rectifier at 233 Kansas St. El Segundo,Calif. 90245 USA

Comparator 134 is preferably a type LM393. When the INTEGRATE line 140goes LOW, the relay 60 in SWITCH block 44 transfers the system from“average” mode to “integrate” mode. A pair of 143 K ohm resistors 142and 144 set the threshold voltage for comparator 134 and a 100 K ohmresistor 146 provides hysteresis.

When the angular movement stops, the RATEOUT signal returns to the NULLvoltage. The window comparators return to the open-collector state,allowing the capacitor 130 to slowly charge through a 1 MEG ohm resistor148. The system 30 remains in the “integrate” mode until capacitor 130charges sufficiently to switch comparator 134, which is approximately0.7 seconds. This allows the system 30 to register any small movementsthe operator may make at the end of a gross movement. Such smallmovements may not otherwise be enough to activate the MOTION DETECTORcircuit 56.

After the 0.7 second delay, comparator 134 switches and the INTEGRATEline goes HIGH, terminating the “integrate” mode. At this point therelay 60 releases and the mechanical shock of the release is sensed byat least one of the sensors causing a noise output on one or moreRATEOUT lines. This noise output can be large enough to retrigger theMOTION DETECTOR circuit 56, resulting in continuous cycling of relay 60.Such undesirable cycling is prevented by resistor 132 delaying dischargeof capacitor 130 until the transient noise caused by the relay releasehas passed. Alternatively, relay 60 may be shock mounted.

Referring now again to FIG. 8, the STARTUP CONTROL circuit 70, POWERSUPPLY circuit 72, and LOW BATTERY DETECTOR circuit 74 may be seen. TheSTARTUP CONTROL circuit 70 has four functions. It generates a masterreset pulse to initialize the system at power on. It provides a threeminute warm-up period for the sensors. It enforces the requirement thatthe sensors not be moving for 10 seconds at the end of the warm-upperiod (to set the “no-motion” reference). It also gives the userfeedback about the system status via the WAIT/READY status of the RUNindicator 22.

An LM 393 type comparator 172 generates a master reset pulse. The pulseis active LOW, with a pulse width of approximately 0.6 seconds,determined by a 1 microfarad capacitor 174 and a 475K ohm resistor 176.The pulse width is selected to be long enough to fully discharge a 10microfarad capacitor 178 (through a diode 180 and a 1K ohm resistor 182)and at least partially discharge a 390 microfarad capacitor 184 (througha diode 186 and a 1K ohm resistor 188). The discharge of capacitors 178and 184 is necessary to handle the situation where the system 30 isturned OFF and then immediately turned ON again. A 1N5817 type diode 190protects comparator 172 and quickly discharges capacitor 174 on powerdown. A 15.0K ohm resistor 192 and a 34.8K ohm resistor 194 provide thereference voltage for comparator 172, and a 475K ohm resistor 196provides hysteresis.

The master reset pulse also clears a WAIT/READY flip flop 198, which ispreferably a 74HC74 type D flip flop. Flip flop 198 is cleared duringthe warm-up or WAIT period and is SET when the system 30 enters theREADY state. Flip flop 198 drives the RUN indicator 22, which ispreferably a yellow/green two color LED driven differentially by the Qand Q-not outputs at pins 5 and 6 of the device 198. Indicator 22 ispreferably illuminated YELLOW during the WAIT or warm-up period, andswitches to a GREEN illumination when the system enters the READY mode.A 392 ohm resistor 200 provides current limiting for the RUN indicator22.

A 10K ohm resistor 202 connected to the Q output (pin 5) of flip flop198 provides an input to the FET transistor 138 which serves as a relaydriver for relay 60. When the system is in the WAIT mode or warm-upperiod, the input provided through resistor 202 forces the system to theAVERAGE mode by connecting the sensors to the AVERAGER amplifiers, sincethe Q output remains LOW during the warm-up period.

An LM 393 comparator 204 is the warm-up timer. A 221K ohm resistor 206and capacitor 184 set the duration of the warm-up period. At the end ofthe warm-up period, the output (at pin 7) of comparator 204 goes to anopen collector condition. This clocks the WAIT/READY flip flop 198 intothe READY state, provided that 10 seconds have elapsed with no motion atthe end of the warm-up period.

The 10 second “no-motion” requirement is enforced by a 10 second timer,which uses an LM 393 type comparator 208. The 10 second timer monitorsthe MOTION signal on line 106 (buffered through another LM 393 typecomparator 210). If any of the sensors detect motion, capacitor 178 willbe held discharged by comparator 210 acting through a diode 212 and a475 ohm resistor 214. When none of the sensors detect motion, capacitor178 will begin to charge through a 1.00 MEG ohm resistor 216. If nomotion is detected for 10 seconds, the output (at pin 1) of comparator208 will go to an OPEN condition, releasing the CLOCK input (at pin 3)of flip flop 198. The result is that the WAIT/READY flip flop is SETonly after both the warm-up period has elapsed, and the system 30 hasnot detected motion for 10 seconds.

The POWER SUPPLY circuit 72 utilizes two integrated circuit voltageregulators 110 preferably LM2931 type, available from NationalSemiconductor Corporation. Regulators 110 and 112 each provide regulated+5 volts DC power to the various circuits shown. Regulator 110 providespower to digital circuits in system 30 (indicated by “+5 D”) andregulator 112 provides power to the analog circuits (particularlyamplifiers 88, as indicated by “+5 A). The sensors, (including ROLLsensor 32) require both analog and digital power. Separate analog anddigital circuit common paths or “ground” traces are used to segregateanalog and digital power supply currents, with the exception that onlythe analog ground is taken to the printed circuit board(s) (not shown)on which the sensors are mounted, because the digital currents are lowin the sensors. A 9 volt battery 272 (see FIG. 9) provides power to theregulators 110, 112 and also to various other components andsubcircuits, such as comparators 98 and A/D converter 114 (shown in FIG.10). A diode 152 protects against reverse battery polarity.

An LM393 type comparator 154 is used for the LOW BATTERY DETECTOR 74.When the battery voltage drops below approximately 6.8 volts, comparator154 switches, driving the signal on the BATLOW 2 terminal 156 LOW,turning on the BATTERY LOW indicator 24, which is preferably a red LED.The LED is supplied through a 392 ohm resistor 158. A precision voltagereference diode 160 sets a reference voltage at the “−” input (pin 2) ofcomparator 154 to 1.2 volts. A 100K ohm resistor 162 and a 21.5K ohmresistor 164 set the voltage at the “+” input (pin 3) of comparator 154to 1.2 volts when the battery voltage is 6.8 volts. A 10 microfaradcapacitor 166 delays the rise of the reference voltage at pin 2 ofcomparator 154 to force the comparator output voltage at the BATLOW 2terminal 156 HIGH at power on. A diode 168 and a 57.6K ohm resistor 170provide hysteresis to lock the output 156 in a LOW state once a lowbattery condition is detected. This prevents the BATTERY LOW indicator24 from cycling ON and OFF in response to changing current demands onthe battery 272, causing the battery voltage to fluctuate above andbelow 6.8 volts.

FIG. 8 also includes the details of the ZERO block or circuit 52. ACD4093 type NAND Schmitt Trigger integrated circuit has a NAND gate 218driving an IRFD 110 type FET transistor 220 which energizes relay 116for the ZERO function (see FIG. 6). One input (at pin 9) of NAND gate218 is connected to the Q output (at pin 5) of the WAIT/READY flip flop198. This holds the system 30 in the ZERO state or condition during thewarm-up period. When the system enters the READY mode, the ZEROcondition is cleared and the INTEGRATOR circuit 48 is enabled. ManualZERO is accomplished by closing a ZERO switch 224 (see FIG. 9) which isconnected between circuit common (“GND”) and an input at pin 8 on NANDgate 218. Pushing the ZERO button closes switch 224, connecting the pin8 input of NAND gate 218 to circuit common, at which time NAND gate 218turns on transistor 220. When the switch 224 is released, it opens,allowing a 0.33 microfarad capacitor 228 to charge through a 750K ohmresistor 230, producing a ZERO pulse of at least 250 milliseconds.

When the system 30 detects motion, the user is given visual feedback byflickering the RUN indicator 22 with GREEN illumination. NAND gates 232and 234 (also type CD4093) form a square wave oscillator with a periodof about 50 milliseconds. When motion is detected, the oscillator isenabled by comparator 134 releasing the input at pin 1 of gate 232 to goHIGH. The oscillator output (at pin 4 of gate 234) drives an IRFD 110type FET transistor 236. When transistor 236 is ON, it increases thecurrent in the RUN indicator LED 22 by providing a path to circuitcommon through a 392 ohm resistor 238. The transistor 236 is turned ONand OFF every 50 milliseconds while the system senses motion, providinga visually perceptible feedback or indication to the user that thesystem 30 is sensing motion.

Referring now to FIG. 9, a wiring diagram for connection of variousparts to the STARTUP CONTROL 70 and ZERO block 52 of system 30 may beseen. It is to be understood that the the connections shown correspondto the lowermost connections on the right hand side of FIG. 8. A powerswitch 14 may be used to provide ON-OFF control of the system 30.Battery 272 is preferably a 9 volt battery. The ZERO switch 224 ispreferably a normally OFF, momentary ON, spring return pushbutton typeswitch.

Referring now to FIG. 10, a portion 240 of the DISPLAY block 40 for theROLL channel 42 may be seen. The output of the ROLL INTEGRATOR block andcircuit 48 is provided on a ROLL INT terminal or line 242. The output ofthe ROLL AVERAGER block and circuit 50 is provided on a ROLL S/Hterminal or line 244. The ROLL INT and ROLL S/H signals are provided tothe analog to digital converter integrated circuit 114 which ispreferably a TC7106 type 3½ digit A/D converter, available fromMicrochip Technology, Inc., 2355 West Chandler Blvd., Chandler, Ariz.85224-6199. The A/D converter 114 contains all the circuitry necessaryfor analog to digital conversion and also provides decoded outputs for a3½ digit LCD display. The ROLL S/H signal is provided to the (−) analoginput and the ROLL INT signal is provided to the (+) input of the A/Dconverter 114. The A/D inputs are thus seen to be connecteddifferentially between the NULL reference voltage and the INTEGRATORoutput. The A/D converter is preferably scaled to display the output inmechanical degrees of rotation. The least significant digit outputprovides tenths of degrees and is not used. The three most significantdigit outputs provide “degrees, tens of degrees, and 100 degrees”respectively. The digital decoded outputs from the A/D converter areconnected to a visually perceptible digital display 18 a, preferably aS401C39TR type LCD display available from Lumex, Inc. of 290 East HelenRoad, Palatine, Ill. 60067. The digital display 18 a simultaneouslydisplays degrees, tens of degrees, 100 degrees, and either a positive ornegative sign to indicate direction of rotation from the ZERO conditionor position. A 10K ohm potentiometer 248 provides a single systemcalibration adjustment for the ROLL channel 42.

Referring now to FIGS. 11 and 12, it may be seen that the PITCH and YAWportions 250 and 260 the DISPLAY block 40 are essentially identical tothe’ ROLL portion 240, each with their own A/D converters 252 and 262and LCD displays 18 b and 18 c, respectively. It is to be understoodthat DISPLAY block 40 include the ROLL, PITCH, and YAW displays 18 a, 18b, and 18 c, and in this embodiment also includes A/D converters 114,252, and 262.

It is to be understood that the ROLL, PITCH, and YAW data (either inanalog or digital form) may be delivered to other circuitry and systems(not shown) in addition to (or as an alternative to) the DISPLAY block40. For example, the digital data representing the final ROLL, PITCH,and YAW angle selected with respect to the reference plane may berecorded by a data logger (not shown) if desired. Furthermore, it is tobe understood that data may be provided in serial form as well as inparallel form, using conventional circuitry to produce serial digitaldata from either the analog values or parallel digital values.

Referring now to FIG. 13, an alternative embodiment of the presentinvention may be seen in a software block diagram 280. In thisembodiment, rate sensor 32 has an output that is immediately convertedto digital form by an A/D converter 282 (which may be the same ordifferent than A/D converter 114. The A/D converter output is thenprovided to a microprocessor-based system 284 which delivers the ROLL,PITCH and YAW information to a DISPLAY 286 which may be the same ordifferent than display 40. This embodiment may also provide the ROLL,PITCH and YAW information to other circuitry or systems (not shown).

In the embodiment of the present invention including accelerometers, thedevice 10 can be utilized independently or in conjunction withgyroscopes or other sensors to provide three dimensional positionalorientation with or without angular change for applications such asosteotomies, placing screws in the pedicle, bone cuts/preparation duringtotal joint arthroplasties, disc replacement, and position of tunnelsfor ligament and tendon repairs. One sensor useful as an accelerometer,either in combination with the gyroscopic sensors, or independently, isan Analog Devices type ADXL103 accelerometer, which may be used in placeof device 32 to detect linear acceleration which is then integrated toobtain linear position (which may be replicated in three orthogonalchannels along x, y and z axes). With the ADXL103 type devices, it isbelieved preferable to include the motion sensing and averaging aspectsshown and described herein, to remove device-to-device errors, as isdone with the gyroscopic type rate sensors. It is to be understood thatif an accelerometer is used to obtain linear position information, twointegrations (from acceleration to velocity to position) are needed.

In another embodiment, the device 10 further includes additional sensorssuch as temperature, ultrasonic, and pressure sensors, for measuringproperties of biological tissue and other materials used in the practiceof medicine or surgery, including determining the hardness, rigidity,and/or density of materials, and/or determining the flow and/orviscosity of substances in the materials, and/or determining thetemperature of tissues or substances within materials. Specificallythese additional sensors can, for example, identify the margins betweencortical and cancellous bone, determine the thickness of cancellousbone, monitor temperature of cement for fixating implants, anddifferentiate between nucleus pulposis and annulus of a spinal disc.Also, these sensors can identify cracks/fractures in bone duringplacement of implants such as pedicle screw placement, screw fixation inbone, femoral implant during THA, and identify tissue-nerve margins todetermine proximity of nerves.

FIG. 14 shows an acetabular alignment instrument 300 for use inobtaining a desired orientation for a prosthetic acetabular socket withrespect to a patient's acetabulum, according to one embodiment of thepresent invention. The use of such an instrument for orthopaedic hipprocedures, such as THR, is well known in the art. One such instrument,for example, is disclosed in U.S. Pat. No. 6,743,235, which is herebyincorporated by reference. The instrument 300 can be any instrumentknown for the placement and orientation of acetabular components,including the preparation instruments for THR procedures.

As shown in FIG. 14, the instrument 300 includes a handle 302, aprosthetic support shaft 304, an orientation shaft 306, the surgicalorientation device 10, and an anatomic benchmark alignment guide 308. Asshown, the surgical orientation device 10 is securely attached to thesupport shaft 304, such that the device 10 moves in concert with thesupport shaft 304. As further shown in FIG. 14, the orientation shaft306 includes an orientation guide 310, which may be used by a surgeonfor manually orienting an implant or prosthetic. In one embodiment, theinstrument 300 does not include an orientation guide 310. The supportshaft 304 has external threads 314 at a distal end. The threads 314 areadapted to mate with corresponding internal threads 316 on the alignmentguide 308, such that the alignment guide is releasably attachable to thesupport shaft 304.

FIG. 15 is a plan view of the top or distal face of the alignment guide308. As shown, the alignment guide 308 includes a body portion 318 andwings or arms 320 a, 320 b, and 320 c, which are disposed generally inthe same plane. The body portion 318 includes internal threads 316 formating with the support shaft 304. In one embodiment, the arms 320secured at points 320 degrees apart around the circumference of the bodyportion 318 by pivots 324 a, 324 b, and 324 c. The pivots 324 allow forslight in-plane rotation of the arms 320 where necessary, for example toavoid contact with an anatomical aberration as the lip of theacetabulum. In another embodiment, the arms 320 are fixed to the bodyportion 318 such that they cannot pivot. In a further embodiment, thepivots 324 are located at any point along the arms 320.

As further shown, the arms 320 include an inner arm 326 and an outer arm328, which are coupled to each other such that the outer arms 328 cantelescope or extend with respect to the inner arms 326. This telescopingaction allows the surgeon to adjust the length of the arms 320, based onthe diameter of a particular patient's acetabulum. In anotherembodiment, the arms 320 are made from a unitary piece and thus are notamenable to a length adjustment. The distal ends of the arms 320 definean outer diameter of the alignment guide 308. The arms 320, in oneembodiment, have a length of from about 40 to about 70 mm, with each arm320 having the same length. The length of the arms is driven by thediameter of a particular patient's acetabulum, such that the outerdiameter of the alignment guide is slightly larger (e.g., 1-3 mm) thanthe diameter of the acetabulum. In various exemplary embodiments, thearms 320 have a length of 48, 52, 56, 60, or 64 mm. In one embodiment,the arms 320 have a width of from about 2 to about 5 mm and a thicknessof from about 1 to about 3 mm. In one exemplary embodiment, the armshave a width of about 3.5 mm and a thickness of about 2 mm.

FIG. 16 shows a perspective view of an attachment base 332 for attachingthe device 10 to the support shaft 304. As shown in FIG. 16, theattachment base 332 includes a body 334 and a brace 336. The body 332 isdimensioned to generally mate with the dimensions of the housing 12 ofthe device 10. In one embodiment, the body 334 includes mounting tabs338 for mating with the housing 12 and fixing the position of the device10 with respect to the attachment base 332. In one embodiment, the body334 includes a groove 339 shaped to mate with the outer surface of thesupport shaft 304. This configuration increases the surface contactbetween the attachment bases 332 and the support shaft 304, whichenhances fixation of the two components. In one embodiment, the body 334includes holes 340 for accepting a fastener, such as string, wire,spring wire, a strap, a hook and loop fastener, or any other fastener.The fastener is used to fix the body 334 to the support shaft 304. Thebrace 336 includes a curve 342 configured to accept the outer surface ofthe orientation shaft 306. The attachment base 332 is attached to theinstrument 300 by placing the body 334 on the support shaft 304 and thecurve 342 of the brace 336 against the orientation shaft 306. In thisposition, the brace 336 resists rotation of the attachment base 332around the circumference of the support shaft 304.

FIG. 17 shows the instrument 300 during use. As shown, the instrument300 is in contact with a portion of the pelvic bone 350. Specifically,the alignment guide 308 is contacting the acetabular rim 352 of theacetabulum 354. As shown, the arms 320 have a length sufficient to reachthe acetabular rim 352. As shown in FIG. 18, the support shaft 304 isalso adapted to mate with a ball support 360, which is used to supportan acetabular prosthetic socket 362.

FIG. 19 is a flowchart illustrating an acetabular alignment process 370for using the alignment instrument 300 to orient an acetabularprosthetic socket 362. As shown, the process 370 includes powering onthe device using the power switch 14 and attaching the device to theshaft of the alignment instrument 300 (block 372). The alignment guide308, having the appropriate diameter, is then attached to the end of thesupport shaft 304 (block 374). After preparation of the surgical siteaccording to standard procedures, the instrument 300 is placed into thesurgical site, such that the alignment guide 308 is resting on the rim352 of the acetabulum 354 (block 376). In one embodiment, the center ofthe alignment guide 308 is generally aligned with the center of theacetabulum 354 and the arms are place on the rim 352 of the acetabulum354, as follows. A first arm is placed on the most superior point of theacetabulum, a second arm is positioned at the lowest point of theacetabular sulcus of the ischium, and a third arm is positioned at thesaddle point at the confluence between the illiopubic eminence and thesuperior pubic ramus. In the absence of a significant acetabular rim,the above anatomic landmarks may be used to identify the plane of theacetabulum.

According to one embodiment, as described above, the arms 320 areadjusted in length by the surgeon using a telescoping action. In anotherembodiment, the surgeon may need to pivot the arms 320 to avoid anosteophyte or other surface aberration on the rim 352 of the acetabulum354. Once the alignment guide 308 is correctly positioned on the rim 352of the acetabulum, the surgeon depresses the zero button 20 to set thereference plane (block 378).

After zeroing the device 10, the surgeon removes the instrument 300 fromthe surgical patient's body. The alignment guide is then removed and theball support 360 and prosthetic socket 362 are attached to the supportshaft 304 (block 380). The surgeon then places the prosthetic socket 362into the acetabulum 354 using the instrument 300 (block 382). Thesurgeon then manipulates the orientation of the prosthetic socket 362 inthe acetabulum 354 using the instrument 300, until the device 10indicates the desired orientation (block 384). In one embodiment, forexample, the surgeon manipulates the instrument 300 until the displays18 on the device indicate an anteversion of 25 degrees. In thisembodiment, the ROLL display 18 a indicates “25” and the PITCH display18 b and YAW display 18 c indicate zero. Next the prosthetic socket 362is secured to the acetabulum 354 (block 386).

In other embodiments, the device 10 is used on other acetabularinstruments to identify the orientation of the instrument with respectto a previously set plane of the acetabulum. When the implant is in theneutral position the information provided by the device may, forexample, be in the form of angular measurements to identify informationsuch as rotation, abduction and version angles. In the embodiment of thepresent invention that includes accelerometers or other sensors forproviding linear positioning information, the device 10 also providesinformation on position changes in linear dimensions to identifyproperties such as depth of insertion and changes in center of rotation.The instrument 300, including the device 10 is capable of sub-millimeterand sub-degree accuracy to monitor the position and angle with referenceto the pelvis. It can provide continuous measurements of cup abductionand flexion angles. These angles may be provided during placement of thepreparation instruments, the insertion of the implant, after it isplaced and, if needed, after placement of supplementary screws.

FIG. 20 shows a femoral implant instrument 400 for aligning the femoralimplant with the greater and lesser trochanter of the proximal femur.The instrument 400 may be, for example, a femoral implant insertioninstrument, a femoral rasp, or a femoral broaching instrument. As shownin FIG. 20, the instrument 400 includes a handle 404, a rasp or broach408, a femoral alignment guide 430, and the device 10. The instrument400 is used to clear and shape the cancellous bone surrounding the canalof the proximal femur 414. The broach 408 is releasably coupled to thehandle 404, such that the surgeon can readily change the broach 408 toone of a different size. The broach 408 is shown in FIG. 20 with thecutting segment embedded in the femur 414. In one embodiment, theinstrument 400 is a femoral broaching instrument such as Broach Handle#4700-RH02, available from Wright Medical Technology, Inc. of Arlington,Tenn. In other embodiments, the broach 408 is any other rasp or broachknown in the art. As shown, the guide 430 is placed on the body 404 atthe desired reference point and attached using the locking mechanism432. As further explained below, the surgeon may use the guide 430 byaligning it with the greater trochanter 418 and the lesser trochanter422 at a proximal end of the femur 414.

FIGS. 21A and 21B are top and side plan views of a femoral alignmentguide 430. As shown, the guide 430 includes a mounting ring 432, alesser trochanter alignment arm 434, and a greater trochanter alignmentarm 436. The alignment arms 434 and 436 extend in generally opposingdirections from the mounting ring 432. As shown in FIG. 21B, thealignment arms 434 and 436 include angles ends 438 and 440,respectively. The angled ends 438 and 440 are usable by the surgeon toalign the guide 430 with respect to the patient's anatomy. The mountingring 432 includes a locking screw 442 for securing the guide 430 to theinstrument 400. In one exemplary embodiment, the greater trochanteralignment arm 436 has a length (l₂) of about 40 percent of a length ofthe lesser trochanter alignment arm 434. In one embodiment, the lessertrochanter alignment arm 434 has a length (l₁) of between about 85 andabout 105 mm. In one embodiment, the alignment arm 434 has a length (l₁)of about 95 mm. In one embodiment, the mounting ring 432 has an internaldiameter (β) of between about 35 and 45 mm. The specific dimensions ofthe alignment guide will depend upon the size of the handle 404 and thepatient's proximal femur 414.

The femoral alignment guide 430 is used to align the femoral implant byreferencing the lesser and greater trochanter of the proximal end of thefemur. The guide 430 can also be used to mark the lesser or greatertrochanter, or any other point marked by the surgeon, to fix thepredetermined/measured angle of the preparation instruments or implant.The surgeon may then move the femur without disrupting his measurementof the chosen anteversion. In one embodiment, the guide 430 is attachedto a femoral broaching instrument. The guide 430 is placed at thedesired angle and the device 20 is set to zero. For example, the guide430, in one embodiment, is generally aligned with a center of thegreater trochanter 418 and the lesser trochanter 422. The surgeon thenturns the instrument 400 to the desired anteversion (e.g., 10 degrees),by using the ROLL display 18 a of the device 10. The surgeon thenloosens the guide 430, rotates it such that the arms 434 and 436 areagain generally aligned with the greater trochanter 418 and the lessertrochanter 422, and secures the guide 430 to the handle 404. The surgeonthen drives the instrument 400 into the canal at this orientation andrepeats this procedure with a larger broach 408, as needed, using theguide 430 to achieve the desired alignment.

The present invention is also useful in assisting a surgeon with a TSRprocedure. In a shoulder replacement, one of the steps is placing aglenoid implant into the glenoid of the patient's scapula. One suchglenoid implant is described in U.S. Pat. No. 6,679,916, which is herebyincorporated by reference. Another step of the TSR procedure isplacement of the humeral implant. The device 10 of the present inventionis useful for assisting a surgeon in achieving proper orientation of theglenoid implant with respect to the glenoid vault and for achievingproper orientation of the humeral implant. The device 10, for example,can be attached to a T-handle or a drill commonly used by the surgeonwith the glenoid planer. The device 10, in further embodiment, can beattached to a tapered reamer used for reaming the humeral canal or to ahumeral head cutting guide.

FIG. 22A shows a side plan view of a glenoid implant insertioninstrument 500 for use in orientation of a glenoid implant. As shown,the insertion instrument 500 includes a shaft 504 and an alignment guide510. FIG. 22B shows a front plan view of the alignment guide 510. Asshown, the alignment guide 510 includes an upper arm 512, a lower arm514, an anterior arm 516, and a posterior arm 518, which are attached toa hub 520. The arms are sized such that they span the glenoid rim for aparticular patient.

FIG. 23 is a flowchart illustrating a glenoid implant alignment process550 for using the implant insertion instrument 500 to orient a glenoidimplant. As shown, the process 550 includes securely attaching thedevice 10 to the shaft of an implant insertion instrument 500 or glenoidplaning instrument (block 554). The alignment guide 510 is attached tothe end of the instrument where the glenoid implant is normally attached(block 556). The guide 510 is placed on the rim of the glenoid, suchthat the upper arm is placed at the most superior position of the rim,and the anterior and posterior arms are generally aligned in the centerof the superior/posterior glenoid (block 558). Again, the arms may beadjusted to avoid significant osteophytes. The “zero” switch is thendepressed to set the displays 18 on the device 10 to zero, which setsthe reference plane (block 560). The alignment guide 510 is removed andthe glenoid implant is attached to the insertion instrument 500 (block562). Finally, the surgeon uses the displays 18 on the device 10 toachieve desired orientation and/or positioning of the glenoid implant(block 564). The surgeon then fixes the glenoid implant in the desiredlocation.

In yet another embodiment, the device 10 is used by a surgeon tofacilitate TKA. For TKA, the device 10 may be affixed to the initialguides commonly used by surgeons, to enable more accurate alignment thanthat provided by the existing guides. In various exemplary embodiments,the device 10 can be affixed to the cutting blocks to provide moreaccurate rotational alignment, varus/valgus alignment, and level ofresection. The device 10 can also be affixed to any other instrumentsknown in the art and commonly employed in a TKA procedure.

With respect the instruments described above, which include sensors forproviding orientation and/or position information, the sensors mayinclude a sensor configured to make a measurement related to the atleast one property at multiple locations on or in the instrument orimplant. According to one embodiment, the sensor includes a plurality oran array of sensors to measure one or more properties over multiplepoints, angles, distance, areas, or any combination thereof.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentinvention. Accordingly, the scope of the present invention is intendedto embrace all such alternatives, modifications, and variations as fallwithin the scope of the claims, together with all equivalents thereof.

1. In an instrument for aligning a medical prosthesis with an anatomical location in, a patient, the instrument of the type having a prosthetic support structure, the improvement comprising an electronic goniometer associated with the prosthetic support structure of the instrument wherein the electronic goniometer includes: a digital display of at least one angle value at which the prosthetic support structure is located; and means for zeroing the angle value of digital display.
 2. The improvement of claim 1 wherein the digital display includes ROLL, PITCH and YAW dimensional angle values.
 3. The improvement of claim 1 wherein the digital display presents the angle value to 0.1 degree.
 4. The improvement of claim 1 wherein the digital display presents the angle value as a signed number indicative of the direction of angular displacement from the reference position.
 5. A surgical instrument for assisting a surgeon in obtaining correct orientation of an acetabular prosthetic socket in a patient's acetabulum, the instrument comprising: a support shaft adapted for supporting the acetabular prosthetic socket; a three-dimensional electronic orientation device securely coupled to the support shaft; and an acetabular alignment guide having at least three arms, the arms having a length sufficient to each contact a rim of the acetabulum.
 6. The instrument of claim 5 wherein the orientation device include a rate sensor that provides a rate signal indicative of a change in angular position of the instrument about an axis.
 7. The instrument of claim 6 wherein the orientation device includes a first rate sensor, a second rate sensor, and a third rate sensor, each disposed about orthogonal axes.
 8. The instrument of claim 5 wherein the orientation device includes a digital display to provide an indication of the change in angular position. 